Abstract Design and project-based learning are critical components of the undergraduate Biomedical Engineering program at Duke University. The design experience culminates in a semester-long design course taken during the senior year. Students select from a set of five one-semester design courses. These courses are divided topically. Each class requires the student to design, build, and test a biomedical device, or evaluate a therapy or process. Each course requires that the student design, build, and test a biomedical device or process. Students provide oral presentations and written reports to document progress and milestones. The semester culminates with a BME Design Fair, at which projects are presented to faculty and students from the entire School. All design courses provide each student the opportunity to be creative, to use the knowledge they have accumulated, and to develop an instrument, tool, or device that is of value to the Biomedical Engineering community. Common content in each course addresses standards, ethics, and intellectual property. Our goal is to create an integrated experience of BME design and translation so that students have the opportunity to be involved in all aspects of the design process including needs finding, project identification, design, prototyping and early stage translation. To enhance the design experience of biomedical engineering students at Duke we will (1) create a course on Medical Device Innovation, through case studies and invited guest lectures, students will learn to identify the key features of successful biomedical devices and the ways in which clinical needs affect device design; (2) establish a clinical needs finding practicum in which rising seniors and Master of Engineering students in BME, who have taken the medical device innovation course, engage in clinical needs finding and project identification at Duke Hospital and develop design project topics; (3) create a formal advanced lab-based design course in which teams fully validate their design, provide detailed product specifications, and develop an initial market assessment and provisional patent application; and (4) integrate the BME design experience with curricular and co-curricular activities in technology translation and entrepreneurship activities at Duke. Students enrolled in this program will be eligible for a certificate recognizing the detailed design experience. These changes will provide a wider range of projects for students; more closely link the projects to clinical applications, and allow students greater involvement in all stages of the design process. A faculty team from BME and clinical departments will organize the program, identify clinical needs finding experiences and provide mentoring. We will assess the program annually with an advisory board that will review student projects as well as surveys of students who complete the program. PUBLIC HEALTH RELEVANCE: This project will provide advanced training for BME seniors and first year graduate students on various aspects of biomedical device needs identification, design and development. As such, the training is expected to better prepare students to be professional engineers and facilitate the development of new devices for clinically important problems.